Implantable scaffold and method

ABSTRACT

A biodegradable device for maintaining the alignment of the edges of a trocar defect, consisting of two bases coupled and offset by a connector. The first base to be positioned below the defect and a second base above. The first base has a threaded hole from its upper surface but not through the lower surface. The connector attached to the bases such that there is a hole aligned with the threaded hole in the first base allowing a device to mate with the threads in the first base. The second base has a hole aligned with the hole in the connector and wide enough to allow a device to mate with the threads in the first base. The device is arranged so the distance between the lower surface of the second base and upper surface of the first base holds the fascia around the trocar defect.

This application is a divisional of application Ser. No. 15/256,595,filed on Sep. 4, 2016, now U.S. Pat. No. 10,166,015, issued on Jan. 1,2019, which in turn claims benefit to Provisional Patent ApplicationSer. No. 62/215,715, filed on Sep. 8, 2015.

BACKGROUND OF THE INVENTION Field of the Invention

The present invention generally relates to a wound closure device thatis used either directly by a surgical team or indirectly as anattachment to a robotics controller to repair the defect typically leftin the fascia layer or other tissue during laparoscopic surgery by aninstrument called a trocar.

Laparoscopic surgery was introduced as an alternative to open surgicalmethods. Also referred to as minimally invasive surgery, the techniqueallows for small incision access to the intra-abdominal cavity. Theapproach utilizes specialized equipment such as robotics for thepurposes of inflating the abdominal cavity with gas, deploying andexchanging instruments during the operation, and real time imaging witha videoscopic camera.

A laparoscopic trocar is a surgical device used for laparoscopicprocedures to pierce and access the wall of an anatomical cavity,thereby forming a passageway providing communication with the inside ofthe cavity. Other medical instruments such as videoscopes and operatinginstruments can thereafter be inserted through the passageway to performvarious medical procedures within the anatomical cavity.

When the procedures are over, the laparoscopic trocars are removed,leaving residual defects in the fascia-peritoneal layer. Laparoscopictrocars are typically 5-15 mm in diameter. The risk of herniationincreases as the trocar size increases, and it is generally recommendedthat any port size larger than 5 mm should be closed because of the riskof hernias. The defect is located deep in the abdominal wall, making itdifficult for the surgeon to view and repair.

Trocar site herniation is a recognized complication of laparoscopicsurgery. Omental, and sometimes intestinal, herniation withincarceration and obstruction has been documented in recent surgicalliterature, occurring at any trocar insertion site larger than 5 mm thatwas not sutured at operation. The need to perform fascial closure of anytrocar insertion site larger than 5 mm has now been established and isroutinely practiced by laparascopic surgeons worldwide.

However, the closure of such a trocar site fascial defect using theconventional suturing technique is often technically challenging,frustrating, unreliably successful, and even sometimes dangerous due tothe limited size of skin incision, the thickness of the subcutaneousfatty layer, and necessity of blind manipulation. Moreover, the suturingthat involves placement of deep blind sutures using a sharp needle afterthe abdomen has been decompressed is a dangerous manipulation thatsurgeons prefer to avoid due to potential complications such as bowelpuncture and injury.

A number of techniques and instruments have been proposed to facilitateclosure of the fascial defect through access of a small skin incision.Most involve passing and tying a suture, in one way or another, from oneside of the trocar wound defect to the other. For this purpose, either atapered suture or a variety of straight needles through which suturesare grasped, have been used. Problems arise as both sides of the defectmay not be sutured. Also, in overweight and obese patients with thickabdominal walls, reliable fascia closure is very difficult to achieve.Inadequate repair results in delayed hernia formation, typicallysymptomatic or incarcerated hernia. A 6% overall hernia complicationrate is reported in patients undergoing bariatric procedures.Re-operation, re-hospitalization, and extended disability frequentlyoccur in those cases.

First generation instruments as the Carter-Thomason or Riza-Ribe®contain a catch on the end of a needle assembly to permit the graspingof a free suture at the edge of a fascial defect. Carter Thomason II andWeckEFx contain grooves, tracks, and guides to mitigate risk of bowelinjury during deployment of the needle and suture positioning.Conventional open repair techniques may also be used and are typicallyindividualized to prevent inadvertent injury to bowel. In one scenario,the handle of a dissecting forceps may be positioned through the fascialdefect to protect the bowel. However, given the tight working space,using this modified open technique is often impractical and notfeasible.

Even with subtle enhancements, the needle dependent Carter-Thomason IIand Weck EFx require positioning of the camera, visualization of theneedles during entry into the peritoneal cavity, feeding of the graspersor suture passers with the suture loop, all of which have to be repeatedfor every trocar defect. These needle techniques are time and effortconsuming, even in the best of hands. As more defects at various sitesin the abdominal wall are to be closed after advanced laparoscopicoperations, the reliance on needle-based closure techniques have becomemore complicated and tedious.

Conventional suturing of the trocar port defect involves much traumaticmanipulation including pushing, pulling and retraction of the wound, andinsertion and extraction of needles. With manipulation and handling ofthe wound, tissue inflammation and risk of ensuing infection riseconsiderably. Patients are subject to pain and complications at theirtrocar sides in the postoperative period. The tissue edema, seroma, andhematoma formation predispose to dehiscence and hernia formation on along-term basis.

Tedious intra-corporeal suturing techniques can be used to close trocarport defects under direct vision from within the abdominal cavity, butthis is rarely done. Instead, most trocar ports are closed from theoutside with the abdominal wall in a flattened configuration. As aresult, the residual defect within the fascial layer is poorlyvisualized by the surgeon.

No matter which suturing technique or needle is used, it is not possibleto eliminate the trocar site hernias completely. As described inMalazgirt (US Patent Application, pub #20060015142 published Jan. 19,2006), the current incidence is reportedly between 0.77-3%. As complexlaparoscopic surgery becomes more common, the incidence of thiscomplication increases. The reported rates of hernia show that there isnot yet any superior method in the safe closure of the trocar fascialdefect.

Eldridge and Titone (U.S. Pat. No. 6,120,539 Issued Sep. 19, 2000)proposed a prosthetic repair fabric constructed from a combination ofnon-absorbable tissue-infiltratable fabric which faces the anteriorsurface of the fascia and an adhesion-resistant barrier which facesoutward from the fascia. This prosthetic requires the use of sutures tohold it in place.

Eberbach (U.S. Pat. No. 5,366,460 Issued Nov. 22, 1994) proposed the useof a non-biodegradable fabric-coated loop inserted through the defectinto the fascia wall, pressing against the posterior fascia wall fromthe intra-abdominal pressure.

Agarwal et al (U.S. Pat. No. 6,241,768 Issued Jun. 5, 2001) proposed aprosthetic device made of a biocompatible non-biodegradable mesh, whichsits across the fascia defect using the abdominal pressure to hold it inplace.

Rousseau (Pat Pub#20030181988) proposed a plug made of biocompatiblenon-biodegradable material which covers the anterior side of the fascia,the defect, as well as the posterior side of the fascia.

Malazgirt (Pat Pub#20060015142) proposed a plug/mesh non-biodegradablecombination for repair of large trocar wounds. It is stated that itrequires at least a “clean flat area around with a radius of 2.5 cm”,and requires staples to hold it in place.

Ford and Torres (Pat Pub#20060282105) proposed a patch with a tether orstrap, all made of non-biodegradable biocompatible material placedagainst the anterior wall of the fascia defect.

Current needle-facilitated closure techniques require that the repair ofthe trocar defect be performed while the trocar is still in place forthe entire closure procedure. If the trocar is completely removed priorto insertion of the device it is difficult to visualize the residualdefect, especially if the trocar is small. Accessing the woundpost-trocar removal would make it difficult to find the residual defect,with a risk of not being able to reliably or anatomically close thedefect.

What is needed is a device for assisting the healing of a trocar woundand method which enables the initial insertion of the device while thetrocar is in place, but allows the completion of insertion of the deviceafter trocar removal.

SUMMARY

A biodegradable device for maintaining the alignment of the edges of atrocar defect, consisting of two bases coupled and offset by aconnector. The first base to be positioned below the defect and a secondbase above. The first base has a threaded hole from its upper surfacebut not through the lower surface. The connector attached to the basessuch that there is a hole aligned with the threaded hole in the firstbase allowing a device to mate with the threads in the first base. Thesecond base has a hole aligned with the hole in the connector and wideenough to allow a device to mate with the threads in the first base. Thedevice is arranged so the distance between the lower surface of thesecond base and upper surface of the first base holds the fascia aroundthe trocar defect.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows the system including the applicator and scaffolding as itwould appear prior to deployment.

FIG. 2 shows the details of one embodiment of the coupling of theapplicator to the scaffold.

FIG. 3 shows the details of another embodiment of the coupling of theapplicator to the scaffold.

FIG. 4 shows one or more embodiments of the scaffold system at the pointwhere the scaffolding is inserted into the abdominal cavity.

FIG. 5 shows one or more embodiments of the coupling of the innerapplicator to the outer applicator.

FIG. 6 shows an embodiment of the inner applicator where it is coupledto the inner scaffold.

FIG. 7 shows an embodiment of the coupling of the inner to the outerscaffolding.

FIG. 8 shows the process of the insertion facilitated through the trocarbut allowing for trocar removal before completion of the process.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

The potential for dislocation of tissue layers is minimized by using theinserted trocar to facilitate the initial placement of the repairingdevice, and then complete the repair task after the trocar is removed.However, removal of the trocar prior to inserting the repair device hasthe advantage of enabling the insertion of larger devices, only limitedby the dimensions of the surgical defect through which the repairingdevice must insert.

It is also understood that one or more embodiments of this device andassociated processes can be used in other surgical procedures whichutilize a laparoscopic procedure going through tissue other than thefascia such as the diaphragm.

FIG. 1 shows views of one or more embodiments of the device configuredto be implanted. A device consists of an inner applicator 106, outerapplicator 104, and the scaffold 108. The outer applicator 104 isconnected to the inner applicator 106 such that the outer applicator 104can slide over a portion of the inner applicator 106.

In one or more embodiments the inner applicator 106 and outer applicator104 are configured to be held by a user by handle 102 attached to theinner applicator 106 to implant and align the device. In otherembodiments, the handle 102, inner applicator 106 and outer applicator104 are configured to be coupled with a robotic device to enable a userto remotely implant the device.

FIG. 2 shows a detailed view of one or more embodiments of the scaffold108 connected to the inner applicator 106. The inner applicator guidedinto place by the outer applicator 104. The inner scaffold 206 is meantto be inserted into the fascia defect and stays underneath the fasciadefect once deployed. The outer scaffold 202 is meant to sit on top ofthe fascia defect. The coupling 208 holds the two scaffolds in place sothat the tissue stays in place, the scaffolds encouraging the healingprocess by providing a scaffold for the tissue to grow. In one or moreembodiments the coupling 208 is ribbed to enable the device to be usedwith various thickness of tissue around the fascia defect. The outerscaffold 202, coupling 208, and inner scaffold 206 will be collectivelyreferred to herein as the scaffold assembly. The mechanical propertiesof the scaffold both maintain alignment of the fascial planes of thedefect during healing and provide a mechanical barrier to herniationduring healing; and until the tissue is sufficiently healed to preventherniation.

FIG. 2 shows another embodiment of a detailed view of the couplingbetween the applicator and the scaffold. The outer scaffold 202 fitsover the inner applicator 106 such that it can be pushed into place bythe outer applicator 104. The inner applicator 106 engages the outerscaffold 202 to secure it in a retracted position during inner scaffold206 deployment. The outer applicator 104 pushes on the outer scaffold202 to enable engagement of the outer scaffold 202 to the inner scaffold206, and to secure the outer scaffold 202 during detachment of the innerapplicator 106 from the inner scaffold 206. In one or more embodiment,the coupling between the inner applicator 106 and outer scaffold 202 iseasily removed without disrupting the scaffold assembly.

In one or more embodiments, the surfaces of the inner scaffold 206 andouter scaffold 202 have features which improve tissue engagement. In oneor more embodiments, a continuous surface will maximize tissue contactand will produce uniform tissue compression. This has the disadvantageof a higher amount of polymer used, increasing cost factor. However,micron-scale porosity allows maximal cellular ingrowth and savesmaterial by minimizing solid density. Although a non-porous surface iseasier to make, the micron-scale porosity enables cellular infiltration,and macro-scale porosity has the potential of causing internal fracturesin the device.

In other embodiments, the use of fenestrations on the surface of thescaffold has the potential for improving mechanical security of thedevice after implantation, and produces potential sites for scaffoldtissue ingrowth. In other embodiments, configuring the device tominimize the effective contact area has the effect to pull tissue in andimprove apposition of tissue, as well as support improved tissue healingby allowing unimpeded blood, oxygen, and nutrient supply. Fenestrationsin the post may facilitate tissue ingrowth between the edges of thedefect in contact on either side of the post (vs the solid constructshown).

In one of more embodiments, the outer scaffold has a convex surfacefacing the inner scaffold. Although a planar surface preserves thenatural planar alignment of the upper inner scaffold 206 and lower outerscaffold surfaces 202, they are not in direct contact with each other.Having a convex surface is easier to deploy as it inherently pushestissue radially outward, minimizing axial compression and relies on thetissue compression on the post. Also minimizing any retraction of theouter scaffold into the fascial layer.

In one or more embodiments, the geometry of the scaffold is lobed. Inone or more embodiments, a circular geometry produces a positionindependent implantation, and maximizes the compression area, but has ahigher polymer cost. In other embodiments, a linear geometry minimizesthe polymer cost, but also minimizes the compression area. A lobeddesign would produce a compromise in that it is mostly positionindependent while lowering the polymer cost.

In one or more embodiments, the inner applicator 106 is attached to theinner scaffold 206 by a threaded connection 208 between the two.

The outer scaffold 202 sits on the superficial surface of the abdominalfascia (Scarpa fascia). It is not necessary for the scaffold assembly tocover the entire defect. Rather, it serves the purpose of stabilizingthe tissue and the edges of the defect anatomically aligned and coaptedto facilitate reliable wound healing.

The scaffold assembly is kept in place to hold, but not overly compress,the tissue surrounding the fascia defect to promote the healing process.In one or more embodiments, the inner scaffold 206 is diametricallylarger than the outer scaffold 202. The purpose of the inner scaffold202 is to anchor the scaffold assembly 108 to the defect, and so it mustbe at least wider than the width of the defect separation, and wideenough to be able to couple with the connector 208. In one or moreembodiments, for 3-5 mm trocar port defects, a single piece scaffoldassembly can be used because it will remove the issue of a postprotrusion and is simpler to implant.

FIG. 4 shows a view of the device after the trocar has been removed andthe scaffold assembly has been placed into position across the fascia404. The outer scaffold 202 is in contact with the outer surface of thefascia 404, while the inner scaffold 206 is in contact with theperitoneal layer of the fascia 404. The inner applicator 106 is stillattached to the outer scaffold 202, but is ready to be removed.

FIG. 5 shows one or more embodiments of the coupling between the innerapplicator 106, and the outer applicator 104. The inner applicator 106is connected to the handle 102 via a threaded assembly 502. This allowsone to separate the geometry of the handle 102 from that of the innerapplicator 106. Also, inner diameter of the outer applicator 504 leavesa space between the inner and outer applicators inside the outerapplicator 104 such that the diameter is wider than the diameter of theinner applicator 106 but smaller than the diameter of the threadedconnector 502. This allows the inner applicator 106 to slide but notfall through the outer applicator 104. In one or more embodiments, theinner applicator 106 and outer applicator 104 have mating threads.During insertion they are threaded together, and this establishes theinitial spacing between the inner scaffold 206 and outer scaffold 202.

FIG. 6 shows one or more embodiments of the coupling between innerapplicator 106 and inner scaffold 206. The inner applicator 106 has athreaded cylinder in the bottom 604 that mates with a threaded barrel ontop of the inner scaffold 206. There is also a barrel 602 that enablesthe inner scaffold 206 to connect to the outer scaffold 202.

FIG. 7 shows one or more embodiments of how the outer scaffold and innerscaffold connect. The barrel 602 has a set of parallel ribs that matewith the inner diameter of the outer scaffold 202. This is a snap-fitrather than a screw mechanism, allowing for setting of a fixed distancebetween the scaffolds. The outer scaffold has a hole in the middle ofthe threads large enough for the inner applicator 106 to pass through.Also, the design of having the two separate parts which are joinedallows one to pick and choose different inner and outer scaffold sizes,the inner scaffold 206 limited to a range between the minimum wounddimension and the trocar size, the outer scaffold 202 should be at leastthe size of the inner scaffold 206. The domed structure of the outerscaffold allows for scaffold to be secured together without the centralpost protruding from through the outer scaffold.

FIG. 8 shows a sequence of the process of implanting the biodegradabledevice. First 802, the device is pushed through the fascia wall 404 withthe outer scaffold 202 retracted while the trocar is still in place 814.Then 804 the trocar 814 can be removed. In one or more embodiments, thispart of the procedure is done when the reversal of anesthetic musclerelaxation takes place, so that the natural tissue muscle tonesurrounding the trocar defect can be used to stabilize the scaffold.

Once the trocar is removed 806, the inner scaffold 206 is pulled upusing the handle 102 so that it is in contact with the inner wall of thefascia 806. Once the inner scaffold is in place, the outer applicator104 is pushed down to place the outer scaffold 202 in place on the outersurface of the fascia 806. When ready to secure the outer scaffold 202to the inner scaffold 206, the outer applicator 104 is first unscrewedfrom the inner applicator 106. The outer applicator 104 is then free tomove independently and coaxially over the inner applicator 104. One canthen advance the outer applicator 104 over the inner applicator 106 sothat the outer scaffold 202 moves against the inner scaffold 206 untilthe scaffolds are fully engaged. In one or more embodiments, thescaffolds are joined by a rapid snap-fit fixation mechanism with fixedsteps. In one or more embodiments, these fixed steps can be 0.1 mm, 0.25mm, 0.5 mm, or 1 mm. Once the scaffold assembly is in place, the innerapplicator 106 can be retracted and the applicators can be detached fromthe scaffold assembly 810. Once retracted, the handle 102 can be turnedto detach the inner scaffold 206 from the outer applicator 106 and theinner applicator 104 can be turned to detach it from the outer scaffold202, leaving the scaffold assembly in place around the fascia to hold itin place while it heals 812.

General Composition of the Wound Closure Device

Materials specified for the wound closure device are specific for itsintended application and use. The scope of materials that will satisfythe requirements of this application is unusually narrow. This is adirect consequence of the specificity and functional demandscharacteristic of the intended surgical application.

The intention for the wound closure device is to close and secure thetrocar port defect in the fascia. This requires a known and finitehealing interval of some three to five months. Its purpose fulfilled atthe end of this period, making continued presence of the closure devicea potential liability. To prevent it from becoming a source forirritation once the healing process is completed, the implanted closuredevice should be removed. Consequently, to avoid the need for a secondsurgical intervention to remove the device, Maurus and Kaeding (Maurus,P. B. and Kaeding, C. C., “Bioabsorbable Implant Material Review”, Oper.Tech. Sports Med 12, 158-160, 2004) found it was a primary requirementfor the wound closure device to be biodegradable. This means that thematerials will degrade or disintegrate, being absorbed in thesurrounding tissue in the environment of the human body, after adefinite, predictable and desired period of time. One advantage of suchmaterials over non-degradable or essentially stable materials is thatafter the interval for which they are applied (i.e. healing time) haselapsed, they are no longer a contributing asset and do not needsubsequent surgical intervention for removal, as would be required formaterials more stable and permanent. This is most significant as itminimizes risks associated with repeat surgeries and the additionaltrauma associated with these procedures.

A disadvantage of these types of materials is that their biodegradablecharacteristic makes them susceptible to degradation under normalambient conditions. There is usually sufficient moisture or humidity inthe atmosphere to initiate their degradation even upon relatively briefexposure. This means that precautions must be taken throughout theirprocessing and fabrication into useful forms, and in their storage andhandling, to avoid moisture absorption. This is not a serious limitationas many materials require handling in controlled atmosphere chambers andsealed packaging; but it is essential that such precautions areobserved. Middleton and Tipton (Middleton, J. and Tipton A. “SyntheticBiodegradable Polymers As Medical Devices” Medical Plastics andBiomaterials Magazine, March 1998) found that this characteristic alsodictates that their sterilization before surgical use cannot be doneusing autoclaves, but alternative approaches must be employed (e.g.exposure to atmospheres of ethylene oxide or gamma radiation with cobalt60).

While biodegradability is an essential material characteristic for thewound closure device, the intended application is such that a furtherrequirement is that the material is formulated and manufactured withsufficient compositional and process control to provide a preciselypredictable and reliable degree of biodegradability. The period ofbiodegradability corresponds to the healing interval for the trocardefect in the fascia layer, which is typically three to five months.

In these materials, simple chemical hydrolysis of the hydrolyticallyunstable backbone of the polymer is the prevailing mechanism for itsdegradation. As discussed in Middleton and Tipton (Middleton, J. andTipton A referenced previously), this type of degradation when the rateat which water penetrates the material exceeds that at which the polymeris converted into water-soluble materials is known as bulk erosion.

Biodegradable polymers may be either natural or synthetic. In general,synthetic polymers offer more advantages than natural materials in thattheir compositions can be more readily finely-tuned to provide a widerrange of properties and better lot-to-lot uniformity and, accordingly,offer more general reliability and predictability and are the preferredsource.

Synthetic absorbable materials have been fabricated primarily from threepolymers: polyglycolic acid (PGA), polylactic acid (PLA) andpolydioxanone (PDS). These are alpha polyesters or poly (alpha-hydroxy)acids. The dominant ones are PLA and PGA and have been studied forseveral decades. Gilding and Reed (Gilding, D. K and Reed A. M.,“Biodegradable Polymers for Use in Surgery” Polymer 20, 1459-1464)discussed how each of these materials has distinctive, uniqueproperties. One of the key advantages of these polymers is that theyfacilitate the growth of blood vessels and cells in the polymer matrixas it degrades, so that the polymer is slowly replaced by living tissueas the polymer degrades (“Plastic That Comes Alive: Biodegradableplastic scaffolds support living cells in three dimensional matrices sothey can grow together into tissues and even whole organs” by Cat FaberStrange Horizonshttp://www.strangehorizons.com/2001/20010305/plastic.shtml)

In recent years, researchers have found it desirable for obtainingspecific desirable properties to prepare blends of these two dominanttypes, resulting in a highly useful form, or co-polymer, designated asPLGA or poly (lactic-co-glycolic acid). Asete and Sabilov (Asete, C. E.and Sabilov C. M., “Synthesis and Characterization of PLGANanoparticles”, Journal of Biomaterials Science—Polymer Edition 17(3)247-289 (2006)) discuss how this form is currently used in a host ofFDA-approved therapeutic devices owing to its biodegradability andbiocompatibility.

In one or more embodiments, the biodegradable wound closure device maybe made of biodegradable material of different stability (i.e.half-life). While it is important for the material that is in directcontact with the fascia or lending support to that (the subfascialbutton base 506, screw 110, and superfascial button base 606) needs tostay in place for a few months, while the rest of the implantablestructure can degrade significantly in a matter of weeks withoutaffecting the performance of the payload. In one or more embodiments,the screw 110 would degrade sooner than the subfascial button base 506and superfascial button base 606, so that the ends of the defect areallowed to grow together while protecting the surface of the defect.

Description of Use of One or More Embodiments of the Invention

One or more embodiments of the use of this invention are describedherein. In one or more embodiments, the outer applicator is coupled tothe outer scaffold first, then the inner applicator is coupled to theinner scaffold through the connector. The outer scaffold is fitted overthe connector. The scaffolds, connector and applicators create what wewill refer to as the applicator assembly.

The applicator assembly is inserted into the wound and the innerscaffold is pushed through the trocar defect. Once the inner scaffold ispushed through the trocar defect, the user exerts a slight upwardpressure on the handle of the inner applicator to keep the innerscaffold securely against the lower fascia surface. In one or moreembodiments where the outer scaffold is made to slide over the connectorthe user will also exert a downward pressure on the tube of the outerapplicator to move the outer scaffold over the connector toward theinner scaffold until there is a positive force pushing back. In otherembodiments, the tube is rotated where the outer scaffold has a threadedinterface with the connector. At this point, the device is in place.

Once the device is in place, the outer applicator can be decoupled fromthe outer scaffold and the inner applicator is decoupled from the innerscaffold. The user is then free to close the outer wound.

Over the next few months, the wound edges will grow into each other. Inone or more embodiments, the tissue may also be encouraged to grow overand/or into the device itself, where the device has a mesh in it. Overtime, the device degrades and eventually dissolves into the body to beexcreted without any known side effects.

What is claimed is:
 1. A process for inserting a biodegradableimplantable device into a trocar defect produced by a trocar placed in afascia wall of a patient, the fascia wall comprising tissue having athickness, the tissue have an inner surface and an outer surface, thebiodegradable device having an inner scaffold, connector, and outerscaffold, the inner scaffold and outer scaffold detachably connected toan applicator and to each other, the applicator having an inner section,outer section and a handle, where the inner section is detachablyconnected to the inner scaffold, the outer section is detachablyconnected to the outer scaffold, the inner section is attached to thehandle, and the inner section is slidable inside the outer section, theprocess comprising: attaching the applicator to the inner and outerscaffold creating an assembly, so that the outer scaffold is on an endof the outer section and the inner scaffold is a distance away from theouter scaffold, the distance being greater than the thickness of thetissue, placing the assembly inside the trocar, pushing the assemblythrough the trocar defect so that the outer scaffold is above the trocardefect and the inner scaffold is below the trocar defect, removing thetrocar while keeping the outer scaffold above the trocar defect and theinner scaffold below the trocar defect, pulling back on the handle sothat the inner scaffold is against the inner surface of the tissue,pushing on the outer section of the applicator until the outer scaffoldis against the outer surface of the tissue, detaching the outer sectionfrom the inner section, pushing down on the outer section while holdingthe inner section in place, until the inner scaffold is engaged with theouter scaffold by an engagement mechanism, retracting the inner section,and detaching the applicator from the scaffold assembly.
 2. The processaccording to claim 1, wherein the engagement mechanism is a snap fitbetween the inner and outer scaffolds with a fixed step size.
 3. Theprocess according to claim 2, wherein the fixed step size is one of 0.1mm, 0.25 mm, 0.5 mm and 1 mm.